NCT06186596

Self-Administered Intralesional Injections for Acne

Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: ACOM Labs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question\[s\] it aims to answer are: * is use of the injection assistance device safe? * is delivery of triamcinolone to acne lesions via the injection assistance device efficacious? Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.

Detailed description

This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites. All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14. Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DEVICE	Triamcinolone delivered via injection assistance device	0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2024-01-02
• Last updated: 2024-01-02

Locations

3 sites across 1 country: United States